Identity
- Trade Name
- Heka Cold/Hot Pack EUDAMED
- Device Name
- Hot/Cold Pack EUDAMED
- Model / Reference
- KW0200-B EUDAMEDKW0100-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886011119 EUDAMED08715886011089 EUDAMED
- Basic UDI-DI
- 8715886HotColdPackAB EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
Heka Cold/Hot Pack by Allion BV h.o.d.n. van Heek Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8715886HotColdPackAB | Class I | Active |
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Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-MF-000003490
Sources (2)
- EUDAMED 9c7e8e3d-7daa-4367-8018-2806ad659499 61 fields · synced Oct 6, 2026
- EUDAMED 185e4bc8-1302-47d7-83ad-9a51cee06fc2 61 fields · synced May 18, 2026